Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Part of paid clinical trials in Pasadena, California.

Sponsor
Immunovant Sciences GmbH
Study ID
NCT05524571
Phase
PHASE3
Status
Completed

Conditions

  • Thyroid Eye Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Batoclimab — DRUG
    Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
  • Placebo — DRUG
    Matching Placebo

Study Details

To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.

Key Dates

Start date
Jan 5, 2023
Status verified
Mar 2026
Primary completion
Feb 3, 2026
Completion
Mar 3, 2026

Study Design

Enrollment
86 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Batoclimab
    Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks.
  • Placebo Comparator: Placebo
    Participants will be administered matching placebo SC weekly for 24 weeks.

Primary Outcome Measure

Percentage of proptosis responders [ Time Frame: At Week 24 ]

Locations (15)

FacilityCityStateZIPSite coordinators
Site Number -1520PasadenaCalifornia91107-
Site Number -1517San FranciscoCalifornia94143-
Site Number -1514TorranceCalifornia90502-
Site Number -1510SarasotaFlorida34239-
Site Number -1516LouisvilleKentucky40202-
Site Number - 1526LivoniaMichigan48152-
Site Number - 1513RochesterMinnesota55905-
Site Number - 1512Winston-SalemNorth Carolina27157-
Site Number - 1525PortlandOregon97239-
Site Number -1515BellaireTexas77401-
Site Number - 1524McAllenTexas78503-
Site Number -1519San AntonioTexas78215-
Site Number - 1521SeattleWashington98104-
Site Number -1511MorgantownWest Virginia26506-
Site Number - 1518MilwaukeeWisconsin53226-

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Site Number -1520· Pasadena, CASite Number -1517· San Francisco, CASite Number -1514· Torrance, CASite Number -1510· Sarasota, FLSite Number -1516· Louisville, KYSite Number - 1526· Livonia, MI

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